Archive | Regulatory

Tebentafusp Named FDA Breakthrough Therapy for Advanced Eye Cancer

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Immunocore‘s tebentafusp (IMCgp100) for HLA-A2 positive, inoperable, or advanced uveal melanoma — a common and difficult-to-treat form of eye cancer — the company announced in a press release.

Read the full story

Posted in Melanoma News, Regulatory, Publications

The Paradoxical Behavior of microRNA-211 in Melanomas and Other Human Cancers

Cancer initiation, progression, and metastasis leverage many regulatory agents, such as signaling molecules, transcription factors, and regulatory RNA molecules.

Read the full story

Posted in Melanoma News, Regulatory, Publications

FDA ‘Fast Tracks’ Toripalimab in Frontline Mucosal Melanoma

The FDA granted a Fast Track designation (FTD) to the humanized PD-1 monoclonal antibody toripalimab for the first-line treatment of patients with mucosal melanoma, announced Junshi Biosciences, in a press release.1

Read the full story

Posted in Melanoma News, Regulatory, Publications, Scientific Publications

The Food and Drug Administration (FDA) grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/ metastatic melanoma

IO Biotech today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy IO102 and IO103 with anti-PD-1 mAb for patients with unresectable/ metastatic melanoma.

Read the full story

Posted in Melanoma News, Regulatory, Publications